ULTRASOUND BREAST SCANNING DEVICE— 510(k) K781177

Substantially Equivalent

Life Instrument Corp.

FDA 510(k) clearance K781177 for ULTRASOUND BREAST SCANNING DEVICE, Substantially Equivalent on 1979-01-03. Applicant: Life Instrument Corp..

Clearance details

Applicant: Life Instrument Corp.
Product code: Code IYO
Advisory panel: Radiology
Date received: 1978-07-06
Decision date: 1979-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.